Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access

Inclusion Criteria: To be considered for enrollment, subjects must: * have been randomized in protocol 012-VWAV06; * have signed and dated an IRB-approved written informed consent to participate in 012-VWAV06 as well as this study; * be willing to comply with all aspects of the evaluation schedule over a period of 60 months post device insertion; * allow representatives of the sponsor, designated Clinical Research Organization (CRO), Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records. Exclusion Criteria: * Subjects who withdrew or were withdrawn from study 012-VWAV06.